A Study of Revlimid for Treatment of Non-hodgkin's Lymphoma - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00413036

Purpose

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin's	Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) In Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

response rate [ Time Frame: every 2 months from the start of study medication until treatement discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reported side effects [ Time Frame: First dose of medication until 30 days after the last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: single arm	Drug: lenalidomide once daily capsule dosing Drug: lenalidomide once daily capsule Other Name: Revlimid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion criteria

Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
Relapsed or refractory to previous therapy for lymphoma
At least one prior combination chemotherapy regime
Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
ECOG performance score of 0,1 or 2
Willing to follow the pregnancy precautions

Key Exclusion criteria

Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- Platelet count < 60,000/mm3 (60 x 109/L).
- Calculated creatinine clearance of <50mL/min
- Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
History of active CNS lymphoma within the previous 6 months
History of other malignancies within the past year
Positive HIV or active Hepatitis B or C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413036

Show 24 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Kenichi Takeshita, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00413036 History of Changes
Other Study ID Numbers:	CC-5013-NHL-003
Study First Received:	December 18, 2006
Last Updated:	July 5, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Celgene
Revlimid
CC-5013
Non-hodgkin's lymphoma

Lenalidomide
CC5013
NHL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012